Clinical Operations Manager - Latin America

May 8

Apply Now

Receive Emails with Similar Jobs

Allucent

WebsiteLinkedInAll Job Openings

Helping bring new therapies to light

Drug Development • Regulatory Affairs and Submissions • Clinical Strategy • Cell & Gene Therapy • Rare Diseases & Orphan Indications

1001 - 5000

Description

• Manages the day-to-day functional and organizational activities of CTAs • Is responsible for resourcing of assigned staff (Monthly Allocation Form completion) • Oversees and manages the assigned staff workload • Provides leadership, mentorship and career development for the assigned staff, including monitoring performance and identifying training needs • Reviews the budgeted and recorded hours to ensure they are within acceptable working limits for active studies for the assigned staff • Assists assigned staff in managing time and tasks to adhere to study budget and timelines • Provides guidance to ensure that assigned staff fulfils responsibilities, to the company and the client, in accordance with company policies and procedures, SOPs, ICH/GCP guidelines, FDA regulations and local regulatory bodies • Liaises with Trial Master File Management department to ensure CTAs are fulfilling filing requirements, meeting project and client timelines; attends assigned project team calls as needed to support the clinical deliverables of the project, and project team member transition meetings • Updates Country Operating & Regulatory Requirements (CORR) as required • Performs interviews of candidates and hiring of new CTAs • Collaborates with Project Management department, with Medical Affairs & Pharmacovigilance department, with Quality Assurance and Compliance department • Conducts performance reviews of assigned staff. Contributes to the process improvement initiatives • Manages feasibilities as required • Supervises CTAs • Actively contribute to staff learning & development within the company • Plans and executes training meetings • Other responsibilities as needed.

Requirements

• At least 7-years’ clinical research experience • Prior experience as a Clinical Trial Associate, Clinical Trial Assistant, or similar positions preferred. • Experience managing teams in the Americas and EU/UK preferred. • Bachelor or higher university degree in life sciences, nursing or medical background preferred • Experience in a leadership capacity or line management • Strong customer service orientation • Demonstrated professionalism and presentation of a positive image of the company • Effective clinical monitoring skills • Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology • Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures • Effective oral and written and presentation communication skills, with the ability to communicate effectively with varied audiences • Effective organizational and time management skills • Proven flexibility and adaptability • Ability to work in a team and to effectively prioritize tasks • Strong ability to work independently and problem solve • Attention to detail • Ability to establish and maintain effective working relationships with co-workers, managers, direct reports, internal and external clients

Benefits

• Comprehensive benefits package per location • Competitive salaries per location • Departmental Study/Training Budget for furthering professional development • Flexible Working hours (within reason) • Opportunity for remote/hybrid* working depending on location • Leadership and mentoring opportunities • Participation in our enriching Buddy Program as a new or existing employee • Internal growth opportunities and career progression • Financially rewarding internal employee referral program • Access to online soft-skills and technical training via GoodHabitz and internal platforms • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees